Home-based Exercise for Improving Health-related Quality of Life in Systemic Sclerosis
ScleroStrong
Home-based Exercise Compared to Usual Care for Improving Health-related Quality of Life in Systemic Sclerosis - a Multicentre Randomised Controlled Trial (the ScleroStrong Trial)
1 other identifier
interventional
270
1 country
3
Brief Summary
The goal of this randomised controlled trial is to evaluate whether a partially supervised, home-based exercise programme in addition to usual care improves health-related quality of life in adults with systemic sclerosis. The main questions it aims to answer are:
- Be randomly assigned to either the partially supervised, home-based exercise programme plus usual care or usual care alone.
- Complete questionnaires at baseline and after 3, 6, 9, and 12 months.
- Undergo physical function assessments at baseline and after 6 months.
- If allocated to the intervention group, perform a 24-week home-based exercise programme consisting of three weekly sessions of aerobic and resistance exercise, supported by six online physiotherapist consultations, followed by 28 weeks of self-guided exercise.
- Complete follow-up assessments of healthcare utilization, productivity, adherence, and adverse events throughout the 12-month study period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2026
CompletedFirst Posted
Study publicly available on registry
September 25, 2026
CompletedStudy Start
First participant enrolled
October 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
Study Completion
Last participant's last visit for all outcomes
September 30, 2029
September 25, 2026
September 1, 2026
1.5 years
September 18, 2026
September 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to 6 months in health-related quality of life measured by the EuroQol 5-dimension 5-Level (EQ-5D-5L).
The EQ-5D-5L is a five-dimension, patient-reported outcome measure designed to assess generic health-related quality of life. The descriptive index ranges from -0.757 (worst health state) to 1.000 (best health state), while the EQ visual analogue scale (EQ-VAS) ranges from 0 (worst imaginable health) to 100 (best imaginable health).
Measured at baseline, 6 months, and 12 months.
Secondary Outcomes (9)
Change from baseline in functional performance measured by the 30-second sit-to-stand test (number of repetitions).
Measured at baseline and 6 months
Change from baseline in aerobic capacity measured by the 2-minute walk test.
Measured at baseline and 6 months
Change from baseline in upper-body functional strength measured by the 30-second arm curl test (number of repetitions).
Measured at baseline and 6 months.
Change from baseline in balance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest).
Measured at baseline and 6 months.
Change from baseline in disease impact measured by the Systemic Sclerosis Impact of Disease (ScleroID).
Measured at baseline, 6 months, and 12 months.
- +4 more secondary outcomes
Other Outcomes (3)
Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs).
Registered continuously during the 24-week intervention and at 6- and 12-month follow-up.
Adherence to the 24-week partially supervised, home-based exercise programme.
Registered by the participants throughout the 24-week intervention period.
Number of participants who withdraw from the study (drop-outs).
Registered from randomisation to the 12-month follow-up.
Study Arms (2)
Partially supervised home-based exercise
EXPERIMENTALParticipants allocated to this arm will receive a 24-week, partially supervised home-based exercise programme in addition to usual care, followed by 28 weeks of self-guided exercise. The programme consists of three weekly exercise sessions including 30 minutes of moderate-intensity walking and three resistance exercises (squat, elastic-band chest press, and elastic-band seated row). Participants will attend six online physiotherapist consultations during the first 24 weeks for exercise instruction, monitoring, progression, and individual adaptation. Exercise progression is based on participants' ability to perform three sets of 10-12 repetitions with acceptable pain and discomfort. Participants will receive instructional videos, exercise equipment (elastic resistance bands), and an exercise diary. The intervention is individually tailored according to disease manifestations, physical function, and exercise tolerance while continuing their usual care.
Usual care
ACTIVE COMPARATORParticipants allocated to the usual care group will continue to receive the standard care provided by their healthcare providers. Usual care may include pharmacological treatment, routine outpatient follow-up, and access to publicly funded group-based physiotherapy according to national practice. The content and extent of usual care may vary between participants depending on disease manifestations and clinical needs. Participants will continue their current treatments and may receive additional treatments if considered appropriate by their treating healthcare providers.
Interventions
The intervention is a 24-week, partially supervised home-based exercise programme consisting of three exercise sessions per week, followed by 28 weeks of self-guided exercise. Each session includes 30 minutes of moderate-intensity walking (Borg Rating of Perceived Exertion 14-15) and three progressive resistance exercises targeting major muscle groups (squat, elastic-band chest press, and elastic-band seated row). Resistance exercises are performed in three sets of 10-12 repetitions and individually progressed by increasing resistance or exercise difficulty according to predefined progression criteria. The programme includes six online physiotherapist consultations during the supervised phase. Instructional exercise videos, elastic resistance bands, and an exercise diary are provided to support the home-based exercise programme. The programme is individually tailored according to disease manifestations, physical function, and exercise tolerance.
Usual care consists of standard clinical management provided by the participant's healthcare providers according to local practice and current national recommendations. This may include pharmacological treatment, routine outpatient follow-up, patient education, and referral to publicly funded group-based physiotherapy where appropriate. The content and intensity of usual care are individualized according to disease manifestations, symptoms, and clinical needs and are not standardized by the study protocol.
Eligibility Criteria
You may qualify if:
- Adults 18 years and older
- Confirmed SSc diagnosis (ACR/EULAR criteria) for ≥6 months
- Able to provide informed consent
You may not qualify if:
- Evidence that the patient cannot participate in a self-guided exercise programme or adhere to study procedures (e.g. due to cognitive impairment)
- Patient cannot understand or speak Danish (for Aarhus University Hospital, Odense University Hospital, and Copenhagen University Hospital - Rigshospitalet) or Italian (for University Hospital of Pisa).
- Patient lacks an email address to receive electronic questionnaires.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Odense University Hospitalcollaborator
- Rigshospitalet, Denmarkcollaborator
- Pisa University Hospitalcollaborator
Study Sites (3)
Department of Clinical Medicine - The Section for Rheumatology, Aarhus University Hospital
Aarhus, 8000, Denmark
Department for Rheumatology and Spine Diseases, Copenhagen University Hospital - Rigshospitalet
Glostrup Municipality, 2600, Denmark
Department of Rheumatology, Odense University Hospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesper L Jensen, MSc
Aarhus University Hospital
- STUDY DIRECTOR
Inger Mechlenburg, Professor
Aarhus University Hospital and Aarhus University
- STUDY DIRECTOR
Esben U Næser, Clin. Ass. Prof.
Aarhus University Hospital and Aarhus University
- STUDY DIRECTOR
John K Brincks, Senior Ass. Prof.
VIA University College
- STUDY DIRECTOR
Marco Di Battista
Pisa University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors are blinded to treatment allocation. Participants are instructed not to disclose their treatment allocation to the outcome assessor during testing.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2026
First Posted
September 25, 2026
Study Start (Estimated)
October 15, 2026
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
September 30, 2029
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be available after publication of the trial.
- Access Criteria
- Data access will be reviewed by the author group. Requesters will be required to sign a Data Access Agreement.
Anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.